UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005709 |
|---|---|
| Receipt number | R000006751 |
| Scientific Title | The validity for accurate identification of GERD in the new questionnaire |
| Date of disclosure of the study information | 2011/06/02 |
| Last modified on | 2014/01/24 16:04:10 |
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Basic information
Public title
The validity for accurate identification of GERD in the new questionnaire
Acronym
The validity for accurate identification of GERD in the new questionnaire
Scientific Title
The validity for accurate identification of GERD in the new questionnaire
Scientific Title:Acronym
The validity for accurate identification of GERD in the new questionnaire
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the varidity for accurate identification of GERD on Japanese subjects using the Gerd Q questionnaire.
Additionally, we will compare the FSSG questionnaire with the Gerd Q questionnaire in relation to the outcomes of sensitivity, specificity, and therapeutic response in a cross-over design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The validity for accurate identification of GERD in the new questionnaire; assessment of sensitivity and specificity for GERD
Key secondary outcomes
The comparison of Gerd Q with FSSG in identification of GERD
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive subjects who fill everything the following;
1)Patient of 20 years or more
2) Patient who gives written informed consent
3)Outopatient with digestive disease symptoms regardless of coexistence of GERD
Key exclusion criteria
The subjects who collide with either the following assumes that it doesn't put it in to the examination;
1) Patients who cannot fill in the questionnaire by themselves
2) Patients who decline to participate in this study
3) Patients who a researcher judges inappropriate for the participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maeda Shin |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
nonaka_taka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
nonaka_taka@yahoo.co.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate the varidity for accurate identification, such as a sensitivity, a specificity and an accuracy, of GERD on Japanese subjects using the Gerd Q questionnaire.
Additionally, we will compare the FSSG questionnaire with the Gerd Q questionnaire in relation to the outcomes of a sensitivity, a specificity, an accuracy and a therapeutic response in a cross-over design.
Management information
Registered date
| 2011 | Year | 06 | Month | 02 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006751
